Direct dual filling device for sealing agents

ABSTRACT

A filling device and method, particularly for two-component sealants such as fibrin sealants, which enables two fluids to be separately and directly filled to the reservoirs of a dual syringe fluid applicator from two storage containers, which can be standardized, sealed, sterilized bottles. The device has a connector which engages with the fluid applicator, is keyed to orient the applicator&#39;s fluid reservoirs in a predetermined manner and holds the containers in side-by-side alignment with the applicator. Two fluid conduits whose downward ends may be pointed to pierce seals on the bottles, extend between the applicator and the bottles and can each have a transverse reach to accommodate the girth of the bottles. The bottles may be tilted by the device to enable the conduits to draw maximal fluid from a lowermost point of the bottle. Tilting can be effected by a downward movement of the device supporting the applicator which movement can introduce the fluid conduits into the bottles. A shroud can enclose and seal the bottles and permit the apparatus complete with fluid applicator to be introduced into a sterile environment. Additionally embodiments for use with a single vial are also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of copending U.S. patentapplication Ser. No. 09/307,056, filed on May 7, 1999, to Epstein et al,now issued U.S. Pat. No. 6,475,183, the subject matter of which ishereby incorporated by reference. This application discloses subjectmatter related to our U.S. patent application Ser. No. 08/838,078, nowissued U.S. Pat. No., 6,331,172, and Ser. No. 08/839,614, now issuedU.S. Pat. No. 5,971,956, both filed Apr. 14, 1997, to patent applicationSer. No. 08/946,364 filed Oct. 7, 1997, now issued U.S. Pat. No.6,007,515, and to patent application Ser. No. 09/037,160 filed Mar. 9,1998, now issued U.S. Pat. No. 6,063,055, all naming Gordon H. Epsteinas first inventor. The disclosures of the aforementioned United Statespatent applications, “the above applications” are hereby incorporatedherein by reference thereto.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a filling device for an applicatorwhich applies multiple fluid sealant components to a work surface and isparticularly, although not exclusively, useful for applying tissuesealant components to biological tissue to effect hemostasis or achieveother therapeutic results. More particularly, it relates to a dualcompartment enclosed direct filling device for a hand-held applicator.

2. Description of Related Art Including Information Disclosed under 37CFR 1.97 and 37 CFR 1.98

Use of tissue sealants and other biological materials is an importantemerging surgical technique, well adapted for the operating room orfield environments such as the doctor's office or mobile medical units.Preferred sealants include fibrin sealants which are formed from bloodplasma components and comprise, on the one hand, a first componentcontaining fibrinogen and Factor XIII and on the other hand a secondcomponent which usually includes thrombin, and calcium ions. Thefibrinogen is capable of a polymerizing and being cross-linked to form asolid fibrin clot when the components are mixed. The necessaryadditional factors to simulate relevant portions of the natural bloodcoagulation cascade are suitably distributed between the fibrinogen andthrombin components.

Antanavich et al. U.S. Pat. No. 5,585,007, whose disclosure andreferences are hereby incorporated herein by reference thereto, providesan extensive discussion of the literature relating to fibrinogen sealantpreparation (column 1, line 20 to column 4, line 62) and applicatorscolumn 4 line 62 to column 5, line 14), as well as a bibliography,(columns 6–10) and is a helpful guide to the teachings of prior workersin the field.

Depending upon the potency of the particular formulations employed,coagulation of the sealant may take place very rapidly, yielding a gelwithin perhaps 10 or 20 seconds. Though often very desirable forsurgical reasons, such fast-acting properties present potential problemsof fouling or clogging. These problems must be overcome in devisingsuitable applicators, methods of application and devices suitable forfilling said applicators.

A popular manually operable applicator for such two-component sealantsemploys a dual syringe construction wherein two syringes, connected by ayoke, each provide a reservoir for one of the components. In most priordevices, the sealant components are discharged in separate streams andmixed externally of the applicator. Such applicators are similar inprinciple to household epoxy glue applicators commonly available inhardware stores.

Until May of 1998, when the FDA first approved such products, fibrinsealant was not commercially available in the US, therefore use offibrin sealant was limited to supplies produced within the clinic, whichare not subject to FDA control.

Current methods of filling biological glue applicators can becomplicated and time consuming. As taught in Epstein U.S. Pat. No.5,266,877 and in our assignee's international applicationPCT/US98/07846, components of the sealant can be placed in separatecompartments in a flat filler tray for transfer to an applicator. Thoughuseful as a device to permit rapid and reliable filling of a dualsyringe applicator at the point of use, such filler trays are notsuitable for external storage of the sealant components. This processcan be time consuming and it requires a significant degree of care toefficiently transfer the sealant to the applicator. Also, a small amountof sealant will be left in the tray, and it is thus wasted. Furthermorethe transfer of sealant components to multiple storage containers raisesthe likelihood in which the sealants will gather bio-burden, andbacteria, which can threaten the sterility of the sealant.

After FDA approval, however, fibrin sealant is now commerciallyavailable in the US. This availability has created a need for aneffective and efficient device useful for transferring the components ofthe sealant, from commercially available or standardized, bottle-likestorage containers, into an applicator.

There is accordingly a need for a device which can effectively deliver,in a sterile environment, multiple sealant components directly fromtheir storage containers to an applicator.

SUMMARY OF THE INVENTION

The present invention solves the problem of effectively deliveringmultiple sealant components directly from commercially available orstandardized storage containers, for example, bottles, to an applicatorwhile allowing the use of the entire fill device within a sterile field.

In one aspect, the invention provides a direct dual filling device forthe multiple sealant components of a liquid sealant, at least two ofsaid components being complementary one to the other and polymerize whenmixed, the direct filling device comprising a body having a plurality ofinlet ports connected to drawing tubes which pierce the protectivecovering of commercially available bottles, the bottles containing thesealant components. The device also having a hood which snaps onto abase thereby enclosing the bottles. within the structure, allowing thedevice to be brought into a sterile field. The base having slantedbottle supports which hold the bottles in a tilted position. Thisfeature allows the drawing tubes to extract virtually all of the fluidcontained within the bottles. The device can be attached to anapplicator with keying such that when the plunger of the applicator isretracted, fluid is drawn from each respective bottle to the properreservoir contained within the applicator. Applications are disclosedfor use with single vials.

The invention enables multiple sealant components to be directlydelivered from their commercially available containers into anapplicator without significant risk of contamination of the sealantcomponents, and with minimal wasting of the sealant components. Thedifferent sealant components are delivered directly from theircontainers into separate individual reservoirs, thereby preventingcoagulation of the sealant components. Once the hood of the device isguided onto the bottles and snapped onto the base, the entire device canbe brought into the sterile environment.

BRIEF DESCRIPTION OF THE DRAWINGS

One way of carrying out the invention is described in detail below withreference to the drawings which illustrate one or more specificembodiments of the invention and in which:

FIG. 1 is a side elevational view of a direct dual filling deviceconnected to an applicator according to the present invention;

FIG. 2 is an enlarged side elevational view of the present invention;

FIG. 3 is a view of the present invention along section lines 3—3 ofFIG. 2;

FIG. 3A is a view similar to FIG. 3 showing an alternate embodimentwherein the hood includes a locking member which comprises an o-ring.

FIG. 4 is a top view of the present invention;

FIG. 5 is a perspective view of the present invention;

FIG. 6 is a perspective view of a direct dual filling device connectedto an applicator according to an alternative embodiment of the presentinvention;

FIG. 7 is an exploded view of an alternative embodiment of the presentinvention;

FIG. 8 is an elevational section view of an alternative embodiment ofthe present invention;

FIG. 9 is an elevational view of an alternative embodiment of thepresent invention;

FIG. 10 is an elevational view of an alternative embodiment of thepresent invention;

FIG. 10 a is a partial elevational view depicting the vial support;

FIG. 11 is an elevational view of an alternative embodiment of thepresent invention;

FIG. 12 is a cut away view showing the hood being lowered onto the baseduring assembly;

FIG. 13 is a cut away view showing the drawing tube held in place by theguide

FIG. 14 is an exploded view showing an alternative embodiment of thehood;

FIG. 15 is an elevational section view of the embodiment shown in FIG.14;

FIG. 16 is a cut away view showing the hood of the embodiment shown inFIG. 14 being lowered onto the base during assembly;

FIG. 17 is a partial cross-sectional view of the embodiment shown inFIG. 14;

FIG. 18 is a frontal view showing a cover of an alternative embodimentof the invention for use with a single vial;

FIG. 19 is a frontal view showing the vial of the embodiment shown inFIG. 18;

FIG. 20 is a frontal view showing the base of the embodiment shown inFIG. 18;

FIG. 21 is a frontal view showing the assembled system of the embodimentshown in FIG. 18 before engagement;

FIG. 22 is a frontal view showing the assembled system of the embodimentshown in FIG. 18 after engagement;

FIG. 22A is an enlarged side elevational view of the embodiment shown inFIG. 22, with portions of the device cut away.

FIG. 23 is a frontal view showing the assembled system without the coverof an alternative embodiment of a single vial system of the invention;

FIG. 24 is a frontal view showing the system with the cover of theembodiment shown in FIG. 23;

FIG. 25 is a frontal view showing the assembled system of an alternativeembodiment of a single vial system of the invention;

FIG. 26 is a frontal view showing a detailed view of the cover andneedle assembly of the embodiment shown in FIG. 25; and

FIG. 27 is a frontal view showing the assembled system of an alternativeembodiment of a single vial system of the invention;

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1 and 2 of the drawings, the direct dual fillingdevice 10 comprises a body 12, a hood 14 and a collar 16 which isadapted to fit an applicator 18. The inventive device is preferablyconstructed out of a clear thermoplastic material such as polycarbonate,polystyrene, polypropylene, polytetrafluoroethylene, acrylonitrilebutadiene-styrene or acrylic, however any suitable material may be used.

Applicator 18 preferably has at least two fluid reservoirs forseparately holding and controllably dispensing reactable fluids, each ofthe fluid reservoirs being connected to a syringe by a fluid conduit.The applicator is of the type primarily used for applying multiple fluidsealant components to biological tissue to effect hemostasis or achieveother therapeutic results.

However the inventive filling device can be adapted to fit applicatorshaving a wide variety of uses which require the direct filling of fluidsinto separate reservoirs located within an applicator.

Located within body 12 are inlet ports 20 and 21 which are adapted toreceive syringes 22 and 23 of applicator 18. Rubber O-rings 34 and 35are positioned within inlet ports 20 and 21 respectively, such that anair tight seal is formed. Inlet ports 20 and 21 are connected to drawingtubes 24 and 25 by transverse channels 26 and 27 respectively, whichdrawing tubes 24 and 25 extend into bottles 28 and 29.

Drawing tubes 24 and 25 should have sufficient length to extractsubstantially all the liquid contained within the bottle, or converselythey should have a length such that when the system is invertedsubstantially all of the liquid can be extracted. Drawing tubes 24 and25 are preferably configured with pointed ends 30 and 31 which have theability to pierce the protective packaging found on standard medicalfluid bottles 28 and 29 and form a seal. Drawing tubes 24 and 25 arepreferably formed out of a metallic material, however any suitablematerial such as thermoplastic may be used. The tubes can also have theability to be removed from support sleeves 32 and 33 for replacement.

Channel 26 allows the fluid contained within right bottle 28 to be drawnthrough tube 24 and into syringe 22 for deposit within the properreceptacle located within applicator 18 without coming into contact withthe fluid contained within bottle 29. Similarly, channel 27 allows thefluid contained within left bottle 29 to be drawn through tube 25 andinto syringe 23 for deposit within the proper receptacle located withinapplicator 18 without coming into contact with the fluid containedwithin bottle 28. This allows the simultaneous filling of both sides ofthe applicator directly from the commercially available containers.Channels 26 and 27 can be formed out of thermoplastic tubing or moldeddirectly into body 12 of the direct filling device 10.

In order to fill applicator 18 directly from bottles 28 and 29, hood 14is placed over said bottles such that pointed tips 30 and 31 areapproximately centered on the protective seal covering the bottles. Thecontoured shape of hood 14 guides the inventive device as the bottlesare seated and snap into place within hood 14 by locking members 40. Asclearly shown in FIG. 3, locking members 40 are located within hood 14such that they move apart when cap 42 of its respective bottle passes byduring the insertion of the bottle, then once the bottle has reached theproper location locking members 40 retract under bottle cap 42 to lockor “seat” the bottles in place. Once the bottles have been seated thesystem may be inverted to ensure that all of the fluid is draw out ofthe bottles. In FIG. 3A, an alternate locking member 40A is illustratedshowing the locking members comprising an o-ring which extends radiallyinward from the hood.

The plunger 19 of applicator 18 is then retracted thereby drawing thefluid contained within bottles 28 and 29 through their respectivedrawing tubes and channels into the syringes of applicator 18 fordeposit within a reservoir.

The direct filling device 10, as shown in FIG. 4, is connected toapplicator 18 by a pair of snap fit members 36. Applicator 18 is placedover the filling device such that the syringes are approximatelycentered over inlet ports 22 and 23, then pressed down until locked inplace by snap fit members 36. The novel shaping of the collar 16 allowsfilling device 10 to mate with applicator 18 in only one orientation,thereby “keying” the fill device to the applicator. The general pentagonshape precisely fits to the applicator body in the same manner asinterchangeable applicator tips or heads, which are used for droplet orspray dispensing of sealant. This feature of keying the filling devicecollar to the applicator ensures the proper fibrin components aredelivered to their respective reservoirs without significant risk ofcross-contamination, particularly when refilling. The agent bottles canonly fit into the fill device hood 14 one way and the applicator can

As depicted in FIG. 5, bottle 29 is inserted into hood 14 until seatedby locking members 40. As can be clearly seen, hood 14 has a recess 44which aides the user in removal of the bottles. Recess 44 is alsouseful, if hood 14 is opaque, to view any labels present on the bottleso it can be verified that the proper components are delivered into theproper reservoirs. Also shown is the contoured shape of hood 14. Theshape can be varied to allow use of different types and shapes ofbottles. The hood can also be modified so that each side allowsinsertion of a different shaped bottle, thereby keying the bottles tothe fill device. This in conjunction with the novel shape of the collaris important in ensuring that the proper components are delivered to theproper reservoirs within the applicator.

The direct dual filling device embodiment shown in FIGS. 6–11 is a moredetailed embodiment of the invention which includes most of the featuresshown in the embodiment of FIGS. 1–5 and is suitable for manufacturingfrom injected molded plastics components. As will be described, severalof the parts of the direct dual filling device shown in FIGS. 6–11embody similar construction and functionality to the components of theembodiment shown in FIGS. 1–5.

Many individual structural features of the components of the direct dualfilling device can be seen from the exploded view of FIG. 7, while FIGS.8–13 show additional structural features and relationships of theinternal components and FIG. 6 shows the overall external appearance ofthe direct tool filling device while in use.

Referring to FIG. 7, the direct dual filling device 100, shown inexploded view, comprises a hood 102, having a first half 104 and asecond half 106, a pair of drawing tubes 108 and 110, a pair of fluidconduits 112 and 114, and a base 116. First-half 104 and second half102, of hood 102 have a pair of drawing tube guides 118 and 120, and apair of recesses 122 and 124. Base 116 has a pair of vial supports 126and 128 which are configured to support vials 130 and 132. Additionally,each of the vial supports 126 and 128 have a vial support surface 134.

Hood 102 can be contoured to resemble the shape of the filling devicewhen assembled with agent vials. The shape can also vary to allow use ofdifferent types and shapes of bottles. The hood can be modified so thateach side allows insertion of a different shaped bottle, thereby keyingthe bottles to the fill device. This in conjunction with the novel shapeof the collar is important in ensuring that the proper components aredelivered to the proper reservoirs within the applicator.

In preferred embodiments, hood 102 and base 116 are essentially rigid,injected molded components having limited resilience in their thinnersections. Hood 102 is also preferably formed from a clear plastic suchas polycarbonate or SAN. In contrast, fluid conduits 112 and 114 arepreferably fabricated from a distinctly elastomeric, resilient moldingmaterial such as silicone rubber.

Once assembled hood 102 is configured to snap into the base by use ofsnap fit members 111. Hood 102 and base 116 are configured such thatthey may only be assembled in one direction, so in use, the operatorcannot assemble the device incorrectly. Base 116 and hood 102 are alsocolor-coded to indicate which side is for the thrombin vial in whichside is for the fibrinogen vial. Furthermore, base 116 is labeled with a“T” indicating the side for thrombin, and an “F” indicating the side forfibrinogen once hood 102 is snapped onto base 116, bottles 108 and 110can be brought into the sterile field.

When assembled, the upper portions of first-half 104 and second half 106combine to form a collar 136, embodying features of collar 16. A pair ofchannels 137 having inlet ports 140 and 142 are also defined within hood102. Channels 137 are configured to retain fluid conduits 112 and 114.

Fluid conduits 112 and 114 comprise a cylindrical cup 144 and a tubulararm 146, which fits suitably within channel 137. Cups 144 are internallyconfigured to be pressed into tight sealing engagement, when so mountedto syringes 22 and 23 of applicator 18, with the ends of sealantcomponents syringes mounted in a mating applicator body, to receiveliquid components therefrom. Tubular arms 146 of fluid conduits 112 and114 are flexible and can readily be manipulated during assembling offilling device 102. The ends of tubular arms 146 are configured to befitted with the ends of drawing tubes 108 and 110 respectively. Thisconfiguration allows liquid components to be drawn through tube 108 intofluid conduit 112 and stored within the respective reservoir locatedwithin applicator 18. Similarly, liquid component may be drawn throughtube 110 into fluid conduit 114 and stored within the other reservoirlocated within applicator 18 without significant risk of contamination.When assembled, the filling device provides an airtight interface fromthe drawing tubes to the applicator reservoir.

Drawing tubes 108 and 110 should have sufficient length to extractsubstantially all the liquid contained within the corresponding vial.Drawing tubes 108 and 110 are preferably configured with a pointed endwhich has the ability to pierce the protective seal found on standardmedical fluid bottles thereby forming a seal. Drawing tubes 108 and 110generally resemble a needle, and are preferably formed out of a metallicmaterial, however any suitable material such as thermoplastic may beused. Both of the tubes may be of similar diameter, however the tubediameter may differ to accommodate liquids having differing viscosities.

Drawing tube guides 118 and 120 are hinged within recesses 122 and 124so that they may be housed within the recesses when the filling deviceused in use. FIG. 13 illustrates the manner in which drawing to 108 isheld in place by drawing tube guides 118. Each of the guides has aforked end 119 which when used in conjunction with one another will holddrawing tube 118 in a vertical position. Recesses 122 and 124 should beof suitable size to allow for variations in the position of the guide,when it is being stored.

Collar 136 is connected to an applicator 18 by a pair of snap fitmembers 138. Applicator 18 is placed over direct dual filling device 100such that the syringes of applicator 18 are approximately centered overinlet ports 140 and 142, then pressed down until in place by snap fitmembers 138. Alternatively, collar 136 may be configured without snapfit members 138. Due to the stability of the device when assembled,applicator 18 can be held in place by a combination of gravity and thefriction generated by the tight nature of the seal formed between thesyringes and the fluid conduits. The novel shaping of collar 136 allowsdirect dual filling device 100 to mate with applicator 18 in only oneorientation, thereby “keying” the fill device to the applicator. Thegeneral pentagon shape precisely fits the applicator body in the samemanner as interchangeable applicator tips or heads, which are used fordroplet or spray dispensing of sealant. This feature of keying thefilling device collar to the applicator insures the proper fibrincomponents are delivered to their respective reservoirs withoutsignificant risk of cross-contamination, and the resulting loss ofmaterials caused by the cross-contamination.

As shown in FIG. 8, first-half 104 of hood 102 has a central divider 148which divides the hood into two compartments 150 and 152, which whenhood 102 is assembled, house vials 130 and 132 respectively. Compartment150 has an upper surface 154 which is slanted from its lowest point atdivider 148 to its highest point at outer wall 156. Similarly,compartment 152 has an upper surface and 158 which is slanted from itslowest point at divider 148 to its highest point at outer wall 160.

Vial supports 126 and 128 are separated by divider slot 162 which isconfigured to receive central divider 148 of hood 102. Vial supportsurface 134 has a slanted outer portion 164, a level central portion166, and an inner slanted U-shaped surface 168. The angle at which theinner and outer portions of vial support surface 134 is constructed, issubstantially parallel to slanted upper surface 154 and 158 of hood 102.Vial support surface 134 has a width which allows vials 130 and 132 tobe suspended by their necks as shown in FIG. 8.

The assembly of the components of filling device 100 can take place at afactory or other such manufacturing facility prior to use of theinventive device. Drawing tubes 108 and 110 are mated with tubular arms146 of fluid conduits 112 and 114. The assembly is then snugly fittedwithin channel 137 such that drawing tubes 108 and 110 all are held byguides 118 and 120 respectively. Preferably, one half of channel 137 isof sufficient proportion to accommodate a greater portion of fluidconduits 112 and 114. This allows the fluid conduits to be placed withinthe larger channel prior to be two halves being assembled, therebyallowing for greater restraint of the conduits prior to assembling thetwo halves of hood 102.

Once the drawing tubes and fluid conduits are in place, first-half 104and second-half 106, of hood 102 are configured to be assembled togetherby snap fit members 105. Alternatively, ultrasonic welding, glue, pressfitting or any other method of assembly may be used. All of thecomponents of the inventive device are then sterilized. When it isdesired to use the inventive filling device the operator need onlyinsert the vials and mate the hood onto the base.

Generally, the agent vials are not sterilized and are unable to bebrought into a sterile environment without risk of contamination.However, when the agent vials are shrouded within the inventive fillingdevice the assembly may be brought into a sterile environment for use.

The operator assembles the device by sliding the agent vials onto vialsupports 126 and 128 such that the necks of the two agent vials areresting on vial support surface 134. The angle at which the outerportion 164 of vial support surface 134 is configured, will cause thetwo agent vials to slide down into place resting on level centralportion 166 of vial support surface 134. The angle is such that frictionwill not stop the bottle from fully seating on level central portion166. As shown and FIG. 10 a vial 130 is properly seated within vialsupport 126 when the center line 180 of vial 130 is positioned at apoint on level central portion 166 further out than pivot fulcrum 182.Pivot fulcrum 182 occurs at the point where level portion 166 transformsinto inner support surface 168. This positioning allows vial 130 to befirmly held in place by support 126, while still allowing vile 130 topivot in the direction of arrow 184. By allowing vial 130 to fully seatwithin vial support surface 134, vial 130 will maintain a level positionduring the first part of the insertion of the drawing tube. This allowsthe needle to properly align with the target area of the vials septum.Since the vials septum has a thin portion in be center which allowsneedles to puncture, it is desirable to align the drawing tube with thistarget area, thereby assuring a good seal.

Once the vials are properly seated, the hood assembly is placed over thebase assembly such that divider 148 is positioned to engage withindivider slot 162 as shown in FIG. 9. As the hood assembly is loweredonto the base in the direction of arrow 170, divider 148 and dividerslot 162 act to align drawing tubes 108 and 110 with the target area ofagent vials 130 and 132.

As the hood assembly is further lowered onto the base in the directionof arrow 170, drawing tubes 108 and 110 puncture the septa of the agentvials creating an airtight interface. As indicated earlier the drawingtubes should be held vertical by their guides and the agent vialspositioned correctly by the vial support face so that the drawing tubespuncture the target area of the septa.

As illustrated in FIG. 12, when guides 118 and 120 come into contactwith the top portion of agent vials 130 and 132 they all are folded upand out of the way into recesses 122 and 124.

FIG. 10 depicts the point at which the top portion of vials 130 and 132comes into contact with upper surfaces 154 and 158. As the housing movesonto the base in the direction of arrow 170, the slanted configurationof upper surface 154 causes agent vial 130 to tilt in the direction ofarrow 172. Similarly, the slanted configuration of upper surface 158causes agent vial 132 to tilt in the direction of arrow 174. The vialsare tilted because the top slanted inner surface of the housing vialcavities are forced down onto the lid of each vial, causing them to tiltto the same angle as the top of the inner cavity.

Simultaneously with the tilting of agent viles 130 and 132, drawingtubes 108 and 110 are driven into the bottom corner of their respectiveviles. Ideally, the sharpened tips of the drawing tubes are shaped suchthat they conform to the shape of the bottom corner of the agent vialsso that as much fluid as possible is drawn up.

Once the hood assembly has been completely lowered onto the base intothe fully engaged position of FIG. 11, it may be locked into place bysnap fittings 111. Agent vials 130 and 132 are tilted in such a mannerthat drawing tubes 108 and 110 are forced into the bottom corner of eachrespective vial, which has now become the low point for the agent topool into. This configuration along with the shaping of the drawingtubes allows for minimal waste of the agent contained within the vials.

Once the inventive filling device is assembled, it may be brought into asterile field. Although, the agent vials are generally not sterile andtherefore would not be allowed within a sterile environment for risk ofcontamination, the hood and base assembly has effectively shrouded thevials within a sterile environment so that they may be brought into asterile field.

FIGS. 14–17 show an alternative embodiment of the inventive device.Referring to FIGS. 14 and 15, hood 102 comprises compliant upper arms103 and 107 which act as compliant tipping arms. Arms 103 and 107 arevertically positioned and have a resilient flexibility to engage and tipvials 130 and 132 as hood 102 is lowered before the needles bottom outon the vials' convexity and hold vials 130 and 132 in tilted position soas to optimize evacuation of the contents of vials 130 and 132. Base 116comprises modified vial supports 126′ and 128′ which are open on eitherside of vials 130 and 132. Thus, a nurse or other user may load a devicewithout touching the base thus avoiding contaminating the sterile field.

Referring to FIG. 16 which shows a view similar to that shown in FIG.12, hood 102 is provided internally with rounded jaws 131 and 133 (notshown) which firmly clasp the tops of vials 130 and 132. Jaws 131 and133 suspend vials 130 and 132 in carved rounded recesses 135 and 139(not shown). The inside of the jaw has a part circular horizontal ledgewhere the bottle can sit vertically. Jaws 130 and 132 and recesses 135and 139 maintain vials 130 and 132 in a vertical position prior totilting as recesses 135 and 139 prevent tilting until the bottom of eachvial is above the recesses. Arms 103 and 107 are vertically positionedand have a resilient flexibility to engage and tip vials 130 and 132 andthe vials tilt after the hood clasps the bottoms of the vials. Base 116is shaped to provide visual guides 117 and 121 to assist the user invisually matching the round and square portion of hood 102 and base 116for alignment and proper orientation. Once assembled hood 102 isconfigured to snap into the base by use of snap fit members 111.

When using the inline body, fibrinogen and thrombin typically take uponly a small portion of the volume of the vial. With most of the vialbeing empty, depressurization is not a problem. Therefore, venting isnot usually necessary. However, most medical personnel are used drawingout a desired volume of liquid from a vial by first injecting the samevolume of sterile air into the vial. Then the syringe automaticallywithdraws the same amount of liquid volume to equalize the pressure inthe vial. However such pressurization may cause problems in that fluidsmay back up into the needles prematurely. Additionally, this method alsocauses air bubbles and inaccurate dosages. Accordingly, venting isdesirable to prevent such undesired pressurization and release unwantedair while maintaining the sterile field. To address this issue, anoversized piece of hypo tube can be used to provide a collar over theneedle which has an inner diameter of 0.002 in greater than the outerdiameter of the needle. When the needle pushes against the collar, itmakes a gap allowing air to escape between the needle and collar.Alternatively as shown in FIG. 17, a pair of dagger-like molded inserts113 and 115 alongside each needle which is against drawing tubes 108 and110 which allow air to escape within the sterile field. If desiredinserts 113 and 115 may be provided with sharply pointed tips or cuttingedges to create a hole alongside the needles which stays open afterpiercing. The hole allows air but not liquid to escape.

Although only two bottles are depicted for use with the inventivefilling device, adaptation can be easily made to allow the use of threeor more, which can directly fill three or more reservoirs containedwithin the applicator. This adaptation can be accomplished by expandingthe hood and adding another inlet port, transverse channel and drawingtube.

During surgery, it is desirable to have access to variable doses ofintravenous drugs. However, due to the limitations of the operatingtheater, syringes are often pre-filled in a separate room under a hoodwhich maintains the sterile field. Current practice for dispensing localanesthetic or saline during surgery is to reach in and out of thesterile field to get more fluids or to dump the fluid into a sterilebowl inside the sterile field. This practice raises the risk of needlesticks, contamination or misuse of a non-labeled fluid in the sterilefield.

Referring to FIGS. 18 to 22, an alternative embodiment of the inventivedevice is shown in the form of a single vial, direct filling device 200having a cover 210 which snaps onto a base 216 thereby enclosing thevial 214 within the structure, allowing device 200 to be brought into asterile field. This device provides needleless filling of fluids fromnon-sterile vials inside the sterile field with reduced waste, whilemaintaining label visibility for application safety. The device consistsof a base or bag, cover and a needle. With this device the vial iscompletely shrouded and can be moved into the sterile field. The deviceis for single use, but multiple fillings. It is understood that thesystem may come with a needle, tube, and/or other structures for matingwith the syringe such as in accordance with one of the embodimentsdescribed above, with one example being shown in FIG. 22A which, whereindicated, identifies similar structures with identical numbers as usedwith previous embodiments, or, alternatively, the syringe may beattached to a needle retracted within a protective cover so that theneedle is only exposed within the sterile environment of the system.

Cover 210 has a hole 211 which receives needle 212 and has a tilted sideportion 213 which accommodates vial 214 tilting. Base 216 has a curvednotch 217 where the neck of vial 214 rests. Vial 214 may be any standardsize vial which is used for intravenous medication. Vial 214 is loadedinto the device and is suspended by its neck. This arrangementaccommodates multiple vial sizes and tilting of vial 214. FIG. 21 showsthe assembled system 200 with vial 214 sitting in base 216 in verticalposition. Rib 218 is tilted before engagement. FIG. 22 shows the deviceafter it is fully assembled and with rib 218 fully engaged. Cover 210has a feature that tilts the vial 214 for maximum fluid removal. Thiscan be achieved while device 200 is sitting on a table in an uprightposition. When fully assembled the non-sterile vial 214 is shrouded andcan be brought inside the sterile field providing a revisitable supplyof medical fluid to the user. Both cover 210 and base 216 are preferablyclear to allow for visual inspection of the vial label and fluid level.

FIGS. 23 & 24 show an alternative embodiment of filler device 200 wherethe syringe can be filled in an upright position while sitting on atable. Filler device 200 does not tilt vial 214, but instead has needle212 extending completely to the bottom of vial 214. More specifically,FIG. 23 shows the inventive device before cover 210 is assembled to it.As shown in FIG. 24, in preferred embodiments, the inventive device 200further comprises locking rings 219 and mating receptacles 220 toaccommodate different vial sizes.

FIGS. 25 & 26 show an alternative embodiment of the device shown inFIGS. 23 and 24. Needle 212 is a short needle which extends just pastthe septum into vial 214. The device is then inverted for filling thesyringe. This embodiment would be useful for withdrawing small volumesof fluid as a longer needle extending to the bottom of the vial maywithdraw air instead of liquid. Inversion of the vial is often desirablefor withdrawing suspensions.

FIG. 27 shows an alternative embodiment of the device shown in FIGS. 25and 26. However, in this embodiment, a plastic bag is used as base 216.More specifically the base 216 comprises a plastic bag that is attachedto the cover 210. When vial 214 is assembled the bag is unrolled andsealed with an adhesive strip. Cover 210 locks vial 214 into place.

While illustrative embodiments of the invention have been describedabove, it is, of course, understood that various modifications will beapparent to those of ordinary skill in the art. Many such modificationsare contemplated as being within the spirit and scope of the invention.

1. A connector for connecting a fluid dispensing instrument to a singlecontainer of fluid having a longitudinal axis, the connector comprising:a) a body having a bottom and a top, said top having an outer perimeterand an outlet port within said perimeter, said bottom having an inletport connected to said outlet port wherein said inlet port is connectedto said outlet port by a bore in said body; b) a collar extending fromsaid perimeter, said collar being adapted to detachably receive saiddispensing instrument; c) a tube is connected to said inlet port andhaving an end distal to said inlet port for extending into saidcontainer, said end having an opening for drawing fluid; and d) a hoodextending from said body and including a base, an exterior surface, anda support surface extending inwardly from the exterior surface and abovethe base; said support surface having a generally laterally extendingslot relative to the longitudinal axis, said slot slidably andreleasably receiving a neck of said single container, said hood having alength sufficient to enclose the container when received by said supportsurface such that once the container is received within said hood, fluidin the container can be drawn into said dispensing instrument throughthe distal end of the tube and the connector substantially encloses thecontainer.
 2. The connector as recited in claim 1 wherein said collar,said body, and said hood are formed of thermoplastic materials.
 3. Theconnector as recited in claim 2 wherein said thermoplastic is selectedfrom the group consisting of polycarbonate, polystyrene, polypropylene,polytetrafluoroethylene, acrylonitrile butadiene-styrene, and acrylic.4. The connector as recited in claim 1 wherein said collar, said body,and said hood are formed as a single thermoplastic member.
 5. Theconnector as recited in claim 1 wherein said tube is formed of ametallic material.
 6. The connector as recited in claim 1 wherein saidcollar is keyed to said dispensing instrument such that said dispensinginstrument may be fitted to said connector in only one orientation. 7.The connector as recited in claim 1 wherein said hood comprises aresilient material and is sized such that when said container ispositioned within said hood, said hood resiliently conforms to fit andsecure said container in place.
 8. The connector as recited in claim 1wherein said hood further comprises a locking member adapted to securesaid container to said connector.
 9. The connector as recited in claim 8wherein said locking member comprises resilient plastic joined to saidhood and extends radially inward from said hood such that when saidcontainer is positioned within said locking member, said locking membersecures said container in place.
 10. The connector as recited in claim 8wherein said locking member is an o-ring fitted within said hood. 11.The connector as recited in claim 1 wherein said outlet port comprises acircular shape.
 12. The connector as recited in claim 1 wherein saidbore is tapered.
 13. The connector as recited in claim 1 wherein saidcollar is capable of making a Luer lock with said dispensing instrument.14. The connector as recited in claim 1 wherein said connector furthercomprises a tubular air vent attached to said connector wherein said airvent further comprises a first opening, a second opening, and a conduitconnecting said first opening to said second opening and said firstopening is positioned such that when said container is locked to saidhood, said first opening is situated inside said container and saidsecond opening is externally situated on said connector such thatpositive air pressure is supplied said container reducing any vacuumforces created within said container during drawing.
 15. The connectoras recited in claim 1 wherein said distal end of said tube has a pointedtip adapted to sealably pierce a cap of said container.
 16. Theconnector as recited in claim 1 wherein said hood is adapted to allowthe container to tilt relative to the connector.
 17. A connector forconnecting a fluid dispensing instrument to a single container of fluidcomprising: a) a body having a bottom and a top, said top having anouter perimeter and an outlet port within said perimeter, said bottomhaving an inlet port connected to said outlet port wherein said inletport is connected to said outlet port by a bore in said body; b) acollar extending from said perimeter, said collar being adapted todetachably receive said dispensing instrument; c) a tube is connected tosaid inlet port and having an end distal to said inlet port forextending into said container, said end having an opening for drawingfluid; and d) a hood extending from said body and including a base, anexterior surface, and a support surface extending inwardly from theexterior surface and above the base; said support surface adapted toslidably and releasably receive said single container, and adapted tosupport the single container suspended above at least a portion of thebase, said hood having a length sufficient to enclose the container whenreceived by said support surface such that once the container isreceived within said hood, fluid in the container can be drawn into saiddispensing instrument through the distal end of the tube and theconnector substantially encloses the container.
 18. A connector forconnecting a fluid dispensing instrument to a single container of fluidcomprising: a) a body having a bottom and a top, said top having anouter perimeter and an outlet port within said perimeter, said bottomhaving an inlet port connected to said outlet port wherein said inletport is connected to said outlet port by a bore in said body; b) acollar extending from said perimeter, said collar being adapted todetachably receive said dispensing instrument; c) a tube is connected tosaid inlet port and having an end distal to said inlet port forextending into said container, said end having an opening for drawingfluid; and d) a hood extending from said body and including a base, anexterior surface, and a support surface extending inwardly from theexterior surface and above the base; said support surface adapted toslidably and releasably receive said single container, and adapted tosupport the single container suspended above at least a portion of thebase in a tilted position relative to the connector, said hood having alength sufficient to enclose the container when received by said supportsurface such that once the container is received within said hood, fluidin the container can be drawn into said dispensing instrument throughthe distal end of the tube and the connector substantially encloses thecontainer.
 19. The connector of claim 17 wherein the single container issuspended above an underside of the base.
 20. The connector of claim 1wherein the support surface is a first support surface and the hoodfurther includes a second support surface which extends radially inwardfrom the exterior surface and is spaced below the first support surface.21. The connector of claim 17 wherein said collar, said body, and saidhood are formed of thermoplastic materials.
 22. The connector of claim17 wherein said collar, said body, and said hood are formed as a singlethermoplastic member.
 23. The connector of claim 17 wherein said tube isformed of a metallic material.
 24. The connector of claim 17 whereinsaid collar is keyed to said dispensing instrument such that saiddispensing instrument may be fitted to said connector in only oneorientation.
 25. The connector of claim 17 wherein said hood comprises aresilient material and is sized such that when said container ispositioned within said hood, said hood resiliently conforms to fit andsecure said container in place.
 26. The connector of claim 17 whereinsaid hood further comprises a locking member adapted to secure saidcontainer to said connector.
 27. The connector of claim 17 wherein saidoutlet port comprises a circular shape.
 28. The connector of claim 17wherein said bore is tapered.
 29. The connector of claim 17 wherein saidcollar is capable of making a Luer lock with said dispensing instrument.30. The connector of claim 17 wherein said connector further comprises atubular air vent attached to said connector wherein said air ventfurther comprises a first opening, a second opening, and a conduitconnecting said first opening to said second opening and said firstopening is positioned such that when said container is locked to saidhood, said first opening is situated inside said container and saidsecond opening is externally situated on said connector such thatpositive air pressure is supplied said container reducing any vacuumforces created within said container during drawing.
 31. The connectorof claim 17 wherein said distal end of said tube has a pointed tipadapted to sealably pierce a cap of said container.
 32. The connector ofclaim 17 wherein said hood is adapted to allow the container to tiltrelative to the connector.
 33. The connector of claim 17 wherein saidsupport surface is inclined to support the container in a non-verticalposition.
 34. The connector of claim 1 wherein said support surface isinclined to support the container in a non-vertical position.